Build a CAPA system that actually prevents recurrence: maturity assessment, problem statements, root cause analysis, action planning, effectiveness checks, KPIs, governance and continual improvement.
نظام الإجراءات التصحيحية والوقائية — دورة فيديو تفاعلية بتعليق صوتي إنجليزي ونصوص ثنائية اللغة (إنجليزي / عربي).
Course modules
- What CAPA Really Is
- Measuring CAPA Maturity
- Documentation and Problem Identification
- Root Cause Analysis
- Corrective and Preventive Actions
- Effectiveness Checks and Metrics
- Governance and Leadership
- Improving Your CAPA System
Instructor: Rafat Alghubari — GxPeria Founder & MD.
For education only — always follow the official guidance and your site procedures.
A practical, risk-based approach to commissioning and qualification — from URS and system classification through design review, FAT/SAT, verification, acceptance and periodic review.
التشغيل التجريبي والتأهيل — دورة فيديو تفاعلية بتعليق صوتي إنجليزي ونصوص ثنائية اللغة (إنجليزي / عربي).
Course modules
- Science and Risk-Based C&Q
- URS and System Classification
- System Risk Assessment
- Design Review and Design Qualification
- C&Q Planning and Vendor Assessment
- C&Q Testing: FAT, SAT, Verification and PQ
- Acceptance, Release and Change Management
- Periodic Review and Legacy Systems
Instructor: Rafat Alghubari — GxPeria Founder & MD.
For education only — always follow the official guidance and your site procedures.
From regulatory expectations to health-based limits, sampling, methods and continued verification — plus five fully worked examples: FMEA, worst-case grouping, PDE → MACO → limits, recovery and Cpu, and bioburden/endotoxin hold times.
التحقق من صحة التنظيف — دورة فيديو تفاعلية بتعليق صوتي إنجليزي ونصوص ثنائية اللغة (إنجليزي / عربي).
Course modules
- Foundations and Regulatory Expectations
- Quality Risk Management for Cleaning
- Cleaning Process Design
- Acceptance Criteria and Health-Based Limits
- Sampling: Swab, Rinse and Recovery
- Analytical and Microbiological Methods
- Qualification and Continued Verification
- Equipment Design, Operations and Change Control
- Worked Example: FMEA for a Shared Line
- Worked Example: Worst-Case Grouping
- Worked Example: PDE → MACO → Swab, Rinse and TOC Limits
- Worked Example: Recovery Factors, Cpu and Control Limits
- Worked Example: Bioburden, Endotoxin and Hold Times
Instructor: Rafat Alghubari — GxPeria Founder & MD.
For education only — always follow the official guidance and your site procedures.